Clinton to Announce FDA Speed-Up for Cancer Drugs

By LAURAN NEERGAARD Associated Press Writer

March 29, 1996

WASHINGTON (AP) - The Food and Drug Administration is telling makers of cancer drugs exactly how they can get the medicines to sick patients faster - as fast as new AIDS drugs are approved.

The FDA has always insisted it would give special ''accelerated approval'' to any drug that offered dramatic hope for cancer,  but manufacturers weren't sure what steps to take to qualify.

New measures being announced today by President Clinton explain that instead of proving a drug prolongs cancer patients' survival or quality of life - lengthy and expensive research to do - they instead could prove simply that it causes a tumor to shrink.

The change could shave at least a year off the time oncology drugs spend being tested and cut in half the FDA's review of them, from 12 months to six. The FDA estimates there are 100 cancer drugs now being tested in Americans that could benefit from the guidelines.

The program is the brainchild of Dr. Michael Friedman, a National Cancer Institute scientist who joined the FDA six months ago under orders to make improvements in how lifesaving drugs are treated.

And FDA Commissioner David Kessler, under increasing scrutiny from a Congress upset that AIDS drugs are approved much faster than medicines for any other disease, earlier this month hinted at the new cancer push.

''If there is an oncology drug and we have reason to believe it works, patients in this country will have access to it,'' he promised a congressional subcommittee.

On Thursday, a Senate committee approved broad legislation that would help Americans get new medical therapies faster and broaden access to European treatments.

Three new AIDS drugs each recently broke FDA records for speedy approvals, the fastest in a mere 42 days.

Yet Rhone-Poulenc Rorer's taxotere, shown to prolong the lives of advanced breast cancer patients - albeit by just a few months - still isn't for sale even though an FDA advisory committee five months ago recommended that it be approved.

While drugs usually are approved based on firm evidence that they cure a disease or prolong life, accelerated approval allows earlier, less sure evidence called ''surrogate markers.'' For AIDS, drugs that boost certain immune cells are allowed for sale as long as the manufacturer later proves they do prolong life.

That fast approval option, developed in 1987, has been open to cancer drugs as well, but the FDA never told manufacturers what surrogate marker to use. Only recently have cancer experts proved that tumor shrinkage is a good predictor to use, explained an official familiar with the oncology program.

The FDA has given accelerated approval to drugs for other diseases: beta seron for multiple sclerosis and Pulmozyme for cystic fibrosis.